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Australian Infant Formula Obtains FDA Import Approval

The Biden administration on Friday took two more actions aimed at alleviating a serious domestic shortage of infant formula.

The Food and Drug Administration has approved the import of infant formula into Australian companies after relaxing strict regulatory requirements aimed at alleviating serious domestic shortages. The Secretary of Health and Welfare, Xavier Besera, also launched a third Defense Production Act in less than a week to help Cargill provide the raw materials used to make infant formula.

Based in Minneapolis, Cargill supplies dozens of products to a variety of infant formula manufacturers, including corn by-products, sweeteners and oils. HHS orders allow the company to order infant formulas prior to orders from other customers who use similar ingredients, allowing them to produce formulas in maximum capacity.

Babs Australia We plan to offer at least 1.25 million cans of several varieties of infant formula, including Babs Organic Grass Fed, Babs Supreme A2 Beta Casein Protein, and Stages 1 and 2 cans of Babs Easy Digest Goat Milk. 8 ounce bottle. According to the FDA, some products are currently in stock for shipping and will be further produced in the coming weeks or months.

The Department of Health and Human Services evaluates the best options for transporting prescriptions to the United States, which are expected to involve the use of commercial air cargo arranged and paid by the US Department of Defense.

This week, the Nestlé Formula from Switzerland was offered by US Air Force freighters and FedEx Express flights as part of a fledgling program known as the Operation Fly Formula.

The FDA exercises enforcement discretion on certain infant formulas after determining that microbiological tests, labeling, and test information meet nutritional adequacy and safety standards. .. The same regulatory flexibility was applied this week as well Danone Nutricia Formula in the UK and Germany and Kendal Nutricare products manufactured in the UK Danone batch is sufficient for 5 million 8 ounce bottles.

“We work 24 hours a day with government partners and industry to ensure that parents and caregivers have access to the right formula for infants whenever and wherever they need it,” said FDA Commissioner Robert Caliph. I am saying. “Steps like the agencies are taking today mean that more infant formulas will be available to parents and caregivers in the weeks and months ahead. Safe and nutritious infants. There is no rest until the shelves are full of milk powder. “

The main focus of the Biden administration is on the special prescriptions that are lacking in infants with allergies and serious health needs. The White House has worked with several agencies to help restore domestic stockpiles by encouraging additional domestic production, coordinating transportation and removing regulatory barriers.

President Biden delegated the decision to approve the Defense Production Act to the HHS Secretary.Sunday, besera Called DPA Allow manufacturers Abbott Nutrition (NYSE: ABT) and Mead Johnson / Reckitt Benquiser to obtain the ingredients and consumables needed to accelerate the production of infant formula.

On Tuesday, the FDA issued guidance outlining how to relax the rules for the US distribution of products manufactured domestically for importing infant formula for overseas markets or for export to overseas markets. Did.

Other Freight Waves / American Shipper stories by Eric Kulisch.

Other things to read:

The FDA has approved an increase in infant formula imports as the air cargo pipeline grows.

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https://www.freightwaves.com/news/bubs-baby-formula-from-australia-gets-fda-import-approval Australian Infant Formula Obtains FDA Import Approval

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